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Multi-limb Dual-task Control in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662009
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : October 30, 2020
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Idaho
Mayo Clinic
Information provided by (Responsible Party):
Tara McIsaac, A.T. Still University of Health Sciences

Brief Summary:
People with Parkinson disease commonly experience difficulty driving, which requires the arms and legs to do different tasks simultaneously. Driving difficulties can lead to isolation, depression, loss of independence and mobility, and increased incidence of car accidents. Through understanding the impact of Parkinson disease on mechanisms underlying attention and multi-limb control, training and rehabilitation programs can better focus on the needs of drivers with Parkinson disease. The proposed study aims to address this need by taking measures of simulated driving at one point in time. Subjects with PD are tested at a single time point when they are at their "best" point in their day and on another day when they are at their worst and are about to take their next dose of medication. Healthy age-matched subjects are not taking anti-parkinson medication so are tested at only one point.

Condition or disease Intervention/treatment
Parkinson Disease Other: multilimb dual task

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Multi-limb Control in Parkinson's Disease: Implicit and Explicit Control of Attention
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Parkinson Disease
Observation of individuals with idiopathic Parkinson disease performing a multilimb dual task using the arm and the leg.
Other: multilimb dual task
control of arm and foot in two attentional contexts of simulated driving
Other Names:
  • Instructed priority
  • constrained accuracy

Control
Observation of healthy age-matched individuals will perform a multilimb dual task using the arm and the leg.
Other: multilimb dual task
control of arm and foot in two attentional contexts of simulated driving
Other Names:
  • Instructed priority
  • constrained accuracy




Primary Outcome Measures :
  1. Dual Task Effect on Arm and Foot Tasks [ Time Frame: Subjects with PD: Two 90-minute sessions within a week; Healthy controls: One 90-minute session, observation of simulated driving. ]
    The Dual Task Effect is the performance measure of the arm and foot task, respectively, in the dual task relative to the single task, expressed as a percentage.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals will be recruited through collaboration with hospitals, clinics, physical therapy centers, private practice physicians and physical therapists, neurology-based fitness centers, community centers, PD support groups, online trial-matching services (e.g., FoxTrialFinder.michaeljfox.org), word of mouth, and advertising. Recruitment will be limited to the greater Phoenix metropolitan area.
Criteria

Inclusion Criteria:

  • have a clinical diagnosis of mild to moderate idiopathic PD (Hoehn & Yahr stages 1-3),
  • hold a valid driver's license and drive at least once a week, and
  • be capable of providing informed consent and complying with study procedures. Control group participants will be healthy, neurologically intact individuals, age-matched to within 2 years of the PD subjects.

Exclusion Criteria:

  • impaired global cognition (i.e., a score of < 20 on the Montreal Cognitive Assessment (MoCA) screening tool)
  • sensory loss in the lower limb as assessed by clinical test of vibration perception at the ankle,
  • orthopedic, visual, or neurological conditions that would prevent performance of the experimental tasks,
  • inability to complete and pass the assessment testing,
  • history of neurological illness such as head trauma, previous stroke, epilepsy, demyelinating disease, or
  • complicating medical problems such as diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662009


Contacts
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Contact: Tara L McIsaac, PhD, PT 480-219-6106 tmcisaac@atsu.edu

Locations
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United States, Arizona
A.T. Still University Arizona School of Health Sciences Recruiting
Mesa, Arizona, United States, 85206
Contact: Research Support Coordinator         
Principal Investigator: Tara L McIsaac, PhD, PT         
Sponsors and Collaborators
A.T. Still University of Health Sciences
National Institute of Neurological Disorders and Stroke (NINDS)
University of Idaho
Mayo Clinic
Investigators
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Principal Investigator: Tara L McIsaac, PhD, PT A.T. Still University
Publications:
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Responsible Party: Tara McIsaac, Professor, A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT03662009    
Other Study ID Numbers: 2017-045
1R15NS098340-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available. Institutional infrastructure being developed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases